A pilot study to prevent post- renal trasplant diabetes in patients at risk

Efficacy of a new formulation of a daily lctp dose of tacrolimus (ENVARSUS®) to prevent diabetes post renal transplant in patients at risk: a controlled randomized open pilot study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000718-52-ES

Enrollment

Unknown

Registered

2017-03-31

Start date

2017-05-09

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes post-renal trasnplant

Interventions

Trade Name: ENVARSUS Product Name: ENVARSUS Pharmaceutical Form: Tablet INN or Proposed INN: tacrolimus monohydrato Other descriptive name: TACROLIMUS MONOHYDRATE Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Patients with end-stage renal chronic disease receiving a live donor transplant or a death donor transplant b) Lack of type 1 or 2 diabetes pre-transplant with ADA criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: a) Double renal tranplant or of another organ b) Unable to understand the protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate if immunosuppression with Envarus reduces the incidence of diabetes post-renal transplant definied by basal glycaemia after glucose overload or the use of antidiabetes drugs compared with prograf in at high risk of diabetes post-transplant patients.;Secondary Objective: Investigate if Envarsus has a beneficial effect in terms of renal function measured with a gold standar (clearance of iohexol), blood pressure, and better lipidic profile after 3 moths of transplant, compared with Prograf in at high risk patients of diabetes post-transplant.;Primary end point(s): diabetes post-transplant;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: Investigate if immunosuppression with Envarus reduces the incidence of diabetes post-renal transplant definied by basal glycaemia after glucose overload or the use of antidiabetes drugs compared with prograf in at high risk of diabetes post-transplant patients.;Secondary Objective: Investigate if Envarsus has a beneficial effect in terms of renal function measured with a gold standar (clearance of iohexol), blood pressure, and better lipidic profile after 3 moths of transplant, compared with Prograf in at high risk patients of diabetes post-transplant.;Primary end point(s): diabetes post-transplant;Timepoint(s) of evaluation of this end point: 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): renal function;Timepoint(s) of evaluation of this end point: 3 months	—

Countries

Spain

Contacts

Public ContactEsteban Porrini

Hospital Universitario de Canarias

3492267 8118

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026